Monthly Archives: June 2015

On April 23, Dean Charney announced the launch of the dynamic new research web portal for the School. Developed as part of the Research Administration Reengineering initiative, it is designed to respond to the needs of our investigators, research staff, and trainees. These key stakeholders and many others actively participated in the successful implementation of this project. The new research web portal guides users to information and tools for starting a research protocol, finding funding opportunities, submitting and managing grants, obtaining approvals, developing technology, and accessing training resources in an intuitive, easy to navigate, and sleekly designed interface. The new “How do I?” section puts all of this information at researchers’ fingertips.

The research web portal is an important milestone in the ongoing effort to enhance the School of Medicine’s web presence. An overhaul of the entire School of Medicine website is currently under way, with the first redesigned section of the new site scheduled to be launched at the end of May. Subsequent sections will be launched in successive phases throughout the remainder of the year.

As Web Marketing and school leadership continue to enhance the research section of the School of Medicine’s website, you may be contacted for information regarding our centers, laboratories, and programs.

The Grants Review Resource (G2R) provides initial comments on research grant proposals from the Mount Sinai research community. The G2R team is currently accepting applications for the July 5th and 16th NIH deadlines. For more information please contact Ravi Iyengar or Karen Johnson by e-mail, or visit the G2R web page to get started.

The use of the new National Institutes of Health (NIH) biographical sketch format is required for all applications due on or after May 25, 2015 per NOT-OD-15-024. A Biographical Sketch, or Biosketch, is required for all key personnel included in NIH grant applications. Applications may be rejected by the NIH if the old biosketch format is used. Creating the new biosketch takes time, so it is important that key personnel start early!

The revised format increases the page limit for the biosketch from four to five pages and includes a new section for researchers to describe up to five of their most important contributions to science. The new biosketch gives the researcher the ability to describe in their own words what makes them a qualified individual for the proposed project. One of the main goals is to focus on actual individual accomplishments and not publication metrics. Reviewers will be able to see and understand immediately the quality of the applicant, instead of inferring capabilities based on a list of citations. That is not to say publications are not important, and they are still included in the new biosketch format. A researcher may include up to four publications for each of the contributions to science.

While creating the new biosketch may be somewhat time consuming, it is important that it be crafted well. Researchers should not worry so much about the number of contributions listed, but should focus on communicating the quality of the work accomplished. Do not be afraid to sell yourself! This is a chance to let reviewers know that you are a qualified, dedicated researcher with all of the skills necessary to carry out the proposed project.

To help researchers make the transition to the new biosketch format, the NIH National Center for Biotechnology Information (NCBI) designed a system – the Science Experts Network or SciENcv – that allows researchers to easily maintain and create biosketches in multiple formats. SciENcv interacts with other electronic systems, eRA Commons and ORCID, to pull information already existing in those databases into a central location. NCBI also already houses a list of publication citations for each investigator via the Bibliography in the MyNCBI portal. This allows the SciENcv system to automatically pull in information and publication citations without the researcher having to type in everything or worry about formatting! The system does it for you!

If you need hands-on assistance with using the SciENcv system or have questions about the biosketch and publications, contact Amanda Norton, Senior Grants Specialist, Grants and Contracts Office at amanda.norton@mssm.edu.

The GCO is building its training and education programs by offering GCO 101 classes aimed at newcomers to the submission process and revamping its training and education webpage. “I am pleased to announce the launch of the GCO 101 classes and the new and improved training and education webpage,” says Jessica Moise, Senior Associate Dean for Sponsored Programs. “We are always striving to provide better service and an easy to understand process in a complex regulatory world. These two initiatives should go a long way in helping to achieve that goal.”

GCO 101
GCO 101 participants learn the basics of the sponsored project and research application submission process at Mount Sinai, including key terms and definitions used in sponsored project administration and best practices for a successful submission. These 1 ¼ hour sessions are generally held the 1st Monday at 3:00 pm and the 3rd Thursday at 9:15 am of each month. The Monday classes are held at the uptown east side Mount Sinai campus, which is a convenient location for many faculty and staff. The Thursday sessions held at the Mount Sinai 150 East 42nd Street campus, GCO headquarters, gives attendees the opportunity to meet GCO staff after the class. “(It’s a) relaxed setting away from campus,” commented one of the participants. Please see the “Upcoming Events” section for session dates and registration information.

GCO’s Training and Education Webpage
The GCO has overhauled its training and education webpage so that it truly reflects the opportunities provided by Mount Sinai, the NIH and other professional organizations dedicated to sponsored projects administration. One highlight is that the site includes the latest training resources that the NIH provides on grants, funding and the peer review process. “NIH’s training material on the grants and funding process is scattered among many different websites across the NIH, CSR, and YouTube and it’s hard to tease out which are the most important or fundamental classes, especially for new applicants to the process,” says Allison Gottlieb, Director of Sponsored Programs Education at the GCO. “Grant Application Basics, for example, is a must for the newcomer. The introductory series includes two NIH videos running only about 20 minutes and much important supplemental information.”

“We would like to say goodbye to applications with errors and delays that can be avoided and make the application submission process as turbulance free as possible,” continues Allison Gottlieb. “And of course we are aiming for more successful and awarded applications. The new, basic GCO 101 submission class coupled with a more robust training and education webpage on the submission process will help us reach these goals.”

Beginning with the implementation of the new Ideate system for IACUC submissions, the IACUC office no longer manages personnel requests via email. Investigators should use the online form at http://osticket.mssm.edu/support/open.php and select the help topic “Ideate/New Personnel Request.” This will ensure that requests are routed as efficiently as possible. If you have any questions or need additional information about IACUC processes and procedures, please contact the IACUC office at iacuc@mssm.edu or 212-241-0153.

In a continued effort to streamline communications between researchers and the IACUC Office, the following IACUC facilitator list has been updated. Department leaders and personnel can refer to this list for their assigned contact within the IACUC office. It is available for download here: IACUC Facilitator Department Assignments.

After more than a year of analysis, research, and planning, the Program for the Protection of Human Subjects (PPHS), in cooperation with Research Information Technology (IT) and the Research Administration Reengineering Program, began implementation of a new electronic submission process for human subject protocols using a software program called Ideate, which will ultimately replace current research submission processes, including InfoEd. Currently, only the IACUC office uses Ideate for reviewing and approving protocols, but eventually all of the research administration offices (including PPHS) will use it and review a single application. Ideate has been customized for the School’s research administrative offices to be an integrated, user-friendly online form that will significantly improve the protocol submission process for investigators and research personnel.

Research Information Technology plans to roll out this exciting system gradually to ensure the system has adequate performance and functionality for every department. It is being implemented in stages for human subject protocols according to this schedule, which was distributed to the research community in May. Exempt applications began migrating to Ideate, effective May 1, 2015, and their migration will be completed by early June 2015. Expedited projects will be submitted through Ideate by August 2015. Finally, Full Board projects will be the last stage of the Ideate rollout for human subjects research, with an anticipated completion in November 2015.

Research personnel and investigators should refer to the Rollout Schedule for their departments’ listings and plan accordingly based on the kind of project they and their research staff will be submitting. The PPHS and Research IT are committed to working closely with research teams, department by department, to provide additional details and assistance as their rollout dates approach.

The PPHS team encourages your feedback over the next several months, as they make this system robust and fix the emerging issues, and thank you in advance for your support during the rollout process. If you have any questions or concerns, please contact the PPHS office at IRB@mssm.edu or call (212) 824-8200.

As of Friday, May 1, 2015, the Program for the Protection of Human Subjects (PPHS) began requiring the use of new consent templates, version date 4/1/2015, for IRB submissions. Version date 4/1/2015 templates highlight the ongoing efforts of the PPHS team to implement the usage of Mount Sinai Health System documents, replacing different site specific boilerplate language with a unified template. In addition, the HIPAA section of the templates has been revised to incorporate all hospitals within the Health System and eliminates the need for stand-alone HIPAA documents for each hospital engaged in the research.

The updated consent forms are now mandatory for the following submissions:

initial submissions to the PPHS,

continuation submissions still active to future enrollment (Note, the currently approved consent document must be transferred over to the latest version even if there are no other changes being requested.), and

modification submissions affecting the consent template.

Research teams can obtain the latest document templates on the PPHS website, in the Forms and Documents Kiosk under “Consent Templates.” For a detailed account of the changes made to these documents, the PPHS has made “tracked changes” versions of the documents available at the top of the page, along with a PDF history of changes, entitled “PPHS Forms and Documents Version Revision History.”

For more information about PPHS templates, procedures, and policies, or if you have questions about these changes, contact the PPHS Office at irb@mssm.edu or 212-824-8200.

For over 50 years the Clinical Research Unit (CRU) had been supported by NIH funding. Established in 1963 as a General Clinical Research Center, the current CRU was partially funded by a Clinical and Translational Science Award (CTSA). However, changes in the funding strategies of the National Center for Advancing Translational Sciences, which funds the CTSA, resulted in withdrawal of support for CRUs nationwide. With support from the Office of the Dean, as of April 2015, the Mount Sinai CRU continues to provide space and personnel to assist ongoing and new studies, but with elimination of CRU-hosted pilot study funding and reductions of ancillary services compared to those offered in past years.

Beginning April 1st, a new fee schedule has been implemented. For non-industry studies, including NIH, MSSM and foundation-sponsored studies as well Investigator Initiated pharma supported projects, the fee is $65 per hour. Industry initiated studies have a fee of $110 per hour.

The center is located on the 2nd floor of 1184 5th Avenue and provides space and personnel to facilitate clinical research studies. The clinical staff includes nurse practitioners, medical assistants, and a dietitian. The CRU offers resources to conduct physical examinations, phlebotomy, drug infusion, ECG, participant monitoring, specimen processing, and other services. There is space for study staff to work while tending to research participants. The unit is in operation 8:00am to 5:30pm, Monday through Friday.

The CRU would like to thank the research community for their patience during the recent transition and looks forward to continuing to provide high quality services to facilitate Mount Sinai clinical research. For applications and for any questions, please contact Christine Hannigan, Clinical Research Manager, 212-241-6045, christine.hannigan@mssm.edu.